FDA names board of CTTI

WASHINGTON The Clinical Trials Transformation Initiative, which was founded by the Food and Drug Administration and Duke University in an effort to improve the quality and efficiency of clinical trials, has named a 12-member executive board that will oversee its activities.

“We hope that by simplifying the way we conduct trials, we can capitalize more quickly on the wealth of recent biomedical advances and develop much better evidence about the balance of benefits and risk of medical technologies,” said Robert Califf, vice chancellor for clinical research at Duke and co-chair of the executive board.

Rachel Behrman, director of the office of Critical Path Programs in the Office of the Commissioner at FDA, will serve as co-chair of the executive board. Judith Kramer, associate professor of medicine at Duke, will serve as the executive director of CTTI.

Other members include:

• Susan Alpert, senior vice president and chief quality and regulatory officer, Medtronic
• David DeMets, professor of biostatistics and medical informatics, University of Wisconsin, Madison
• Kenneth Getz, senior research fellow, Tufts Center for the Study of Drug Development
• Glenn Gormley, senior vice president, global clinical development and medical affairs, Novartis Pharmaceuticals
• Alberto Grignolo, corporate vice president and general manager, drug development consulting, PAREXEL consulting, representing the Association of Contract Research Organizations
• Nancy Roach, C3: Colorectal Cancer Coalition
• Jay Siegel, group president, research and development, biotechnology, immunology and oncology, Johnson & Johnson
• Lana Skirboll, associate director, science policy, National Institutes of Health
• Robert Temple, Office of Medical Policy and Office of Drug Evaluation I in the Office of New Drugs, Center for Drug Evaluation and Research, FDA
• Bram Zuckerman, director, Division of Cardiovascular Devices, Center for Devices and Radiological Health, FDA

One of the first tasks of the executive board will be to define the group’s strategy and prioritize areas for projects that do “research on research.”